TEMIZOLE 5 temozolomide 5 mg capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

temozolomide, Quantity: 5 mg

Available from:

Viatris Pty Ltd

INN (International Name):

Temozolomide

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: indigo carmine; colloidal anhydrous silica; iron oxide yellow; stearic acid; titanium dioxide; lactose; purified water; Gelatin; sodium starch glycollate; tartaric acid; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administration route:

Oral

Units in package:

5 Capsules, 15 Capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment.,Treatment of recurrence of anaplastic astrocytoma and glioblastoma multiforme following standard therapy.,Temozolomide is also indicated as a first-line treatment for patients with advanced metastatic malignant melanoma.

Product summary:

Visual Identification: Green/White hard gelatin capsules, size 3, imprinted 'TMZ' on the cap and '5' on the body containing white to light pink powder.; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2011-07-19

Patient Information leaflet

TEMIZOLE
®
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®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING TEMIZOLE?
TEMIZOLE contains the active ingredient temozolomide. TEMIZOLE is used
to treat patients with brain tumours. TEMIZOLE is also
used to treat adult patients with advanced metastatic malignant
melanoma.
For more information, see Section 1. Why am I using TEMIZOLE? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TEMIZOLE?
Do not use if you have ever had an allergic reaction to TEMIZOLE or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
TEMIZOLE? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TEMIZOLE and affect how it works.
Tell your doctor or pharmacist if you are taking any other
medicines, including any medicines, vitamins or supplements that you
buy without a prescription from your pharmacy, supermarket
or health food shop.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE TEMIZOLE?
•
Your doctor has worked out the exact dose of TEMIZOLE for you
according to your individual needs.
•
Each time you start a new treatment cycle, be sure you understand
exactly how many capsules of each strength you need to
take on each day of dosing.
More instructions can be found in Section 4. How do I use TEMIZOLE? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TEMIZOLE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
TEMIZOLE.
•
Tell your doctor if you feel sick or vomit while being treated with
TEMIZOLE.
THINGS YOU
SHOULD NOT DO
•
Do not open the capsules. If a capsule is damaged, avoid contact with
your skin, e

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
TEMIZOLE
® 5/20/100/140/180/250
_temozolomide capsules _
1
NAME OF THE MEDICINE
Temozolomide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each TEMIZOLE capsule contains 5 mg, 20 mg, 100 mg, 140 mg, 180 mg or
250 mg of temozolomide as the
active ingredient.
Excipients with known effect: Contains sulfites and sugars as lactose.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
TEMIZOLE 5 mg: Green/White hard gelatin capsules, size 3, imprinted
'TMZ' on the cap and '5' on the body
containing white to light pink powder.
TEMIZOLE 20 mg: Yellow/White hard gelatin capsules, size 5, imprinted
'TMZ' on the cap and '20' on the
body containing white to light pink powder.
TEMIZOLE 100 mg: Pink/White hard gelatin capsules, size 3, imprinted
'TMZ' on the cap and '100' on the
body containing white to light pink powder.
TEMIZOLE 140 mg: Transparent blue/White hard gelatin capsules, size 1,
imprinted 'TMZ' on the cap and
'140' on the body containing white to light pink powder.
TEMIZOLE 180 mg: Maroon/White hard gelatin capsules, size 1, imprinted
'TMZ' on the cap and '180' on the
body containing white to light pink powder.
TEMIZOLE 250 mg: White/White hard gelatin capsules, size 0, imprinted
'TMZ' on the cap and '250' on the
body containing white to light pink powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TEMIZOLE is indicated for the treatment of:
•
newly diagnosed glioblastoma multiforme concomitantly with
radiotherapy and then as adjuvant
treatment.
•
recurrence of anaplastic astrocytoma and glioblastoma multiforme
following standard therapy.
TEMIZOLE is also indicated as a first-line treatment for patients with
advanced metastatic malignant
melanoma.
4.2
DOSE AND METHOD OF ADMINISTRATION
Antiemetic therapy may be administered prior to or following
administration of temozolomide.
Temozolomide capsules should be administered in the fasting state at
least one hour before a meal. If vomiting
occurs after the dose is administered, a second dose